# COMPETE

Source: https://onco.cc/trials/compete/  
OnCo record `compete` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first head-to-head trial of a radioligand against a targeted pill in neuroendocrine tumours; the radioligand won on progression-free survival.

## Summary

COMPETE, trial NCT03049189 sponsored by ITM Isotope Technologies Munich and published in the Lancet in 2025, was the first head-to-head trial of a radioligand against a targeted tablet in neuroendocrine tumours, and the radioligand won on progression-free survival. It randomised 309 patients with progressive grade 1 to 2 somatostatin-receptor-positive gastroenteropancreatic tumours to 177Lu-edotreotide or everolimus, met its primary progression-free survival endpoint with a significantly higher response rate, and showed an interim overall survival trend that was not significant; the result supports an FDA filing with a PDUFA date of 28 August 2026. OnCo links it to peptide receptor radionuclide therapy, somatostatin receptor 2, 177Lu-edotreotide, everolimus and Jonathan R. Strosberg. Whether a second lutetium agent differentiates from lutetium dotatate is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03049189
- Phase: 3
- Setting: Progressive grade 1-2 SSTR-positive GEP-NETs: 177Lu-edotreotide vs everolimus
- Sponsor: ITM Isotope Technologies Munich
- Enrolled: 324
- Result: PFS 23.9 vs 14.1 months, HR 0.67.
- Outcomes: Progression-free survival: 177Lu-edotreotide 23.9 months vs Everolimus 14.1 months, HR 0.67; Overall survival (interim): 177Lu-edotreotide 63.4 months vs Everolimus 58.7 months, HR 0.78

## Sources

- ClinicalTrials.gov NCT03049189: https://clinicaltrials.gov/study/NCT03049189
- CancerNetwork: COMPETE: https://www.cancernetwork.com/view/itm-11-demonstrates-superior-pfs-vs-everolimus-in-sstr-gep-nets

## Connected records

- collections: [CancerNetwork (ONCOLOGY)](https://onco.cc/collections/src-cancer-network/)
- cancers: [Grade 3 well-differentiated neuroendocrine tumour](https://onco.cc/cancers/grade-3-net/), [Neuroendocrine tumours](https://onco.cc/cancers/neuroendocrine/), [Pancreatic neuroendocrine tumours](https://onco.cc/cancers/pancreatic-net/), [Small intestinal neuroendocrine tumours](https://onco.cc/cancers/small-intestinal-net/)
- technologies: [Peptide receptor radionuclide therapy (PRRT)](https://onco.cc/technologies/prrt/)
- targets: [Somatostatin receptor 2](https://onco.cc/targets/sstr2/)
- drugs: [177Lu-edotreotide](https://onco.cc/drugs/itm-11/), [Everolimus](https://onco.cc/drugs/everolimus/)
- companies: [ITM Isotope Technologies Munich](https://onco.cc/companies/itm/)
- people: [Jonathan R. Strosberg](https://onco.cc/people/jonathan-strosberg/)
- ideas: [Dosimetry-personalised PRRT instead of four fixed cycles](https://onco.cc/ideas/idea-net-dosimetry-prrt/), [SSTR antagonist radioligands to increase tumour dose](https://onco.cc/ideas/idea-net-antagonist-ligands/)

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JSON: https://onco.cc/api/v1/entities/compete.json